FOLFOXIRI as Primary Treatment for Locally Advanced Pancreatic Cancer

Phase II Study of FOLFOXIRI as Primary Treatment for Stage III Unresectable Locally Advanced Pancreatic Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02351219

Acronym

FLAP

Enrollment

Registered

2015-01-30

Start date

2012-12-31

Completion date

2014-12-31

Last updated

2015-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Carcinoma Stage III

Brief summary

The study is conducted as a monocentric prospective phase II trial. Patients with unresectable stage III locally advanced pancreatic cancer (defined for extended encasement of superior mesenteric artery/celiac axis/hepatic artery or for combined venous and arterial involvement or for unreconstructible venous encasement), ECOG PS 0-1 and age 18-75 are eligible. After multidisciplinary evaluation of resectability, treatment with FOLFOXIRI is provided for a maximum of 12 cycles with multidisciplinary evaluation of disease status every 4 cycle. In case of tumors have deemed resectable surgery is considered. In case tumors remain unresectable, radiotherapy is evaluated after the end of chemotherapy. Primary objective of the study is the rate of patients who become resectable and undergo radical surgical resection after chemotherapy. Secondary objectives are: response rate, progression-free survival, overall survival, toxicity.

Interventions

DRUGFOLFOXIRI

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Stage III unresectable pancreatic cancer defined for: * extended encasement of superior mesenteric artery or celiac axis/hepatic artery * both arterial and venous (portal vein/superior mesenteric vein) encasement * unreconstructible vessel encasement * ECOG Performance Status 0-1 * Age 18-75 * Adequate liver, renal and bone marrow function

Exclusion criteria

* Evidence of distant metastases * Cardiovascular diseases * Contraindications to studied drugs

Design outcomes

Primary

Measure	Time frame
Radical resection rate	6 months

Secondary

Measure	Time frame
Progression-free survival	Within 24 months

Other

Measure	Time frame
Overall survival	Within 36 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	within all the treatment period

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026